The U.S. FDA has proposed an update to an existing program for user fee reductions for companies grossing less than $100 million, although this latest update is much stingier than that. The update would provide registration fee relief for entities with revenues of $1 million or less, but only if that business is in bankruptcy proceedings, a meager bit of relief considering that registration fees in fiscal 2024 run to less than $7,700.
Shiratronics Inc. seeks patent protection for a rechargeable subcutaneous neurostimulator implant and a method for managing heat during recharge of its battery from an external device and headset.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, EDAP TMS, Medtronic.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arteraai, Becton Dickinson, Bone Biologics, Clinical Microbiomics, DNASense, Cytomed, Diacarta Inc., Isightec, Nonagen Bioscience.
Global interest in radiopharmaceuticals is soaring, and the global radiopharma market is expected to grow 10% over the next decade to $13.67 billion by 2032, according to a new report by Precedence Research.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Siemens Healthineers, Varian.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alayacare, Avita, Axonics, Biophotas, Irhythm, Lifeward, Medtronic, Rewalk, Smartalpha, Thermo Fisher.
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